Clinical Program Manager/Senior Clinical Program Manager, Clinical Operations

REVOLUTION Medicines is an exciting, early stage biotechnology company that discovers and develops innovative drugs for cancer patients directed toward frontier oncology and immune-oncology targets.  The company draws inspiration from evolution and natural products that are inherently rich with biological function. REVOLUTION Medicines deploys an innovative toolkit including REVBLOCKS, an integrated suite of rapid, agile, and modular synthesis methodologies applied to simple chemical “building blocks,” and the REVEAL computational platform, which uses evolution’s lessons to inform selection of chemical scaffolds guide drug design for non-classical drug targets. As a new member of the RevMed team, you will join other outstanding clinical scientists and professionals who are helping lead our efforts in the development of new medicines for unmet needs in cancer.

Opportunity

This is a unique opportunity for an experienced Clinical Operations Professional who has technical expertise in managing Phase I-III clinical trials in an industry setting and a strong knowledge of clinical operations, Good Clinical Practice (GCP) and U.S. Food and Drug Administration (FDA) regulatory requirements. Oncology experience is preferred. As the Clinical Program Manager/Sr. Clinical Program Manager of Clinical Operations, you will be responsible for Contract Research Organization (CRO) oversight and execution of Revolution Medicines clinical studies.

Specifically, you will be responsible for:

  • Management of clinical studies and vendors to ensure studies are completed on time, within budget and in compliance with Standard Operating Procedures (SOPs), FDA regulations and International Council for Harmonisation (ICH)/ GCP guidelines.

  • Identify, engage and manage the activities of clinical CROs and other clinical study providers (e.g. core labs, Electronic Data Capture (EDC) provider, and independent contractors) to execute clinical trials.

  • Review and contribute to the development of study-specific documentation including clinical trial protocols, case report forms, study guides/manuals, informed consent forms and clinical database.

  • Review monitoring reports and other study documentation as required.

  • Oversee the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF).

  • Participate in team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, DMPK, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals

  • Follow up on assigned team action items and identify, escalate, and resolve issues as needed

  • Collaborate with contracts specialist to review and negotiate Clinical Trial Agreements and

site specific study budgets.

  • Assess adequacy/feasibility of potential clinical investigators and sites including evaluating facilities, personnel, patient referral base, and adherence to GCP.

  • Develop clinical study monitoring priorities and Monitoring Plan in conjunction with CRO.

  • Conduct site visits (e.g., training visits, site initiation visits, monitoring visits), as required.

  • Manage investigational product accountability and reconciliation process.

  • Assist with the preparation of safety, interim and final clinical study reports, and resolution of data discrepancies.

  • Provide clinical trial support, mentoring, leadership, guidance and direction to Clinical Research Associates (CRAs) assigned to clinical studies.

  • Prepare and track study participant enrollment projections vs. actuals and study budgets

  • Serve as primary clinical operations contact for internal and external (clinical sites, vendors, etc.) teams for assigned studies.

  • You will be a key member of the Clinical Operations team initially reporting to the Director, Clinical Operations.

Required Skills
  • BS or MS degree or other suitable qualification with relevance to the field of clinical operations.

  • Minimum 5+ years of industry experience, preferably the majority in oncology.

  • Hands-on experience of running early-stage clinical trials within an industry environment.

  • Experience of clinical trial operations outside the USA is desirable, but not essential.

  • Strong working knowledge of FDA Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials.

  • A demonstrable record of strong vendor management and teamwork.

  • Direct experience of managing clinical CROs.

  • Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.

  • Excellent written and verbal communication skills.

  • Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important.

  • Ability to travel (~25%).


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